Kornimate/medical-research-clean huggingface dataset:
lucid registry study

Conditions: Barrett Esophagus; Esophageal Adenocarcinoma; Barretts Esophagus With Dysplasia; Barrett's Esophagus Without Dysplasia

Summary: this is a multicenter, prospective, observational study designed to capture a limited set of data consisting of diagnostic test results and clinical management information on subjects who undergo ec/eg to assess for the presence of be/eac. once sufficient time has elapsed for esoguard results to be available, as well as for any subsequent clinical evaluation to have been performed (e.g., upper endoscopy and any initial therapeutic management), study staff will obtain the desired information and record it in an electronic data collection (edc) system, pertaining to subject demographics, pertinent medical history, and risk factors for be or eac as well as (1) information about the esocheck cell collection procedure and patient tolerance, (2) esoguard test result; (3) initial clinical management including upper endoscopy, if performed, and diagnosis (as determined by the endoscopist and the pathologist assessing any biopsies taken), as well as (4) additional clinical management and/or a therapeutic procedure(s) performed. the time point for collecting such information shall be fluid, depending on the time course of care provided subsequent to the esoguard result being available. it is expected typically to be approximately 4 months given the systemic delays in scheduling and performing upper endoscopies and obtaining biopsy results. there is no a priori limit on the timeline for obtaining these data, but it is . anticipated that all data collection will be completed within 8 months of the availability of esoguard results.


Eligibility criteria:
inclusion criteria: 1. males and females who have provided informed consent for prospective registry participation 2. subject in whom the clinical decision has been made to screen for be/eac using esoguard testing on samples collected with esocheck exclusion criteria: 1. inability to provide written informed consent 2. subjects who fall outside the eligible population defined by the esocheck device instructions for use (ifu)
efficacy of human chorionic gonadotropin in acute gvhd treatment

Conditions: Acute Graft Versus Host Disease

Summary: graft-versus-host disease is a complication of allogeneic hematopoietic cell transplantation with high morbidity and mortality. the standard treatment is corticosteroids, and based on the response within 3 to 7 days, a second-line therapy is added, which is expensive and not easily accessible. the administration of human chorionic gonadotropin has shown therapeutic effectiveness in 50% of patients in reported clinical cases.

the study will include 20 patients with recent-onset allogeneic hematopoietic cell transplantation and gvhd who attend the hematology service at the university hospital and meet the inclusion criteria, to receive conventional treatment with steroids (prednisone 1 mg/kg/day for 14 days) or combined treatment (hcg 2500 iu, im + prednisone 1 mg/kg/day for 14 days).

Eligibility criteria:
inclusion criteria: * aged 18 years or older. * any gender. * post-allogeneic transplantation status (haploidentical or identical) of hematopoietic cells. * presenting recently onset agvhd, grades 2 to 4, and requiring systemic steroid use as determined by the treating physician. * have not received steroids (prednisone ≥1 mg/kg/day or equivalent dose of another steroid) for more than 3 days in the last week. * willing to participate in the study by signing informed consent. * if the subject is female and has the potential to procreate (a woman is considered fertile from menarche to postmenopausal stage or after undergoing a permanent contraceptive method), she agrees to use one of the following contraceptive methods from the start of the study and for 30 days after the protocol: oral hormonal contraception, intrauterine device, barrier methods (diaphragm, male or female condom, and foam, sponge, or spermicide film), or agrees to remain abstinent. women who have been postmenopausal for more than a year, undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy are not considered to have reproductive potential. * if the subject is male, he agrees to use one of the following contraceptive methods from the start of the study and for 30 days after the protocol: male condom, or remain abstinent. exclusion criteria: * arterial or venous thrombosis in the past 3 months. * history of thromboembolic disease requiring full-dose anticoagulation. * diagnosis of active malignant disease. * uncontrolled infection. * chronic use of supplemental therapy with sex hormones (estrogen, progesterone, and/or testosterone). * women with a positive pregnancy test at the time of the initial evaluation. * women or men of reproductive age who are unwilling to take appropriate precautions to avoid an unwanted pregnancy from the start of the protocol until 30 days after the protocol.

Keywords: acute gvhd human chorionic gonadotropin
pharmacokinetics and safety/tolerability after oral administration of ckd-387 and d484 in healthy adults

Conditions: Type II Diabetes

Summary: randomized, open-label, single-dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability after oral administration of ckd-387 10/1000 mg and d484 10/1000mg in healthy adults


Eligibility criteria:
inclusion criteria: * healthy volunteers between the ages of 19 and 55 * body weight ≥ 55kg for male, ≥ 50kg for female * body mass index ≥ 18.5 kg/m2 and \< 25.0 kg/m2 * females who are post-menopausal or underwent sterilization * males who agreed to practice contraception until after 28 days of last intake investigational product * ability to provide written informed consent exclusion criteria: * subject with clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease and psychosis disorder * subject who are weak in dehydration or clinically significant dehydration * iv injecting examination of radioactive-iodine substances within 48 hours prior to first ip administration * subjects who have galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption * subjects with history of gastrointestinal disease or surgery that may affect absorption of ip * hypersensitive to dapagliflozin/metformin * at screening, * ast(aspartate transaminase), alt(alanine transaminase) \> unl(upper normal limit)\*1.25 * total bilirubin \> unl(upper normal limit)\*1.5, cpk \> unl(upper normal limit)\*1.5 * egfr(estimated glomerular filtration rate) \< 60 ml/min/1.73m2(modification of diet in renal disease calculated) * positive reaction on following tests: hepatitis b, hepatitis c, hiv(human immunodeficiency virus) and syphilis * sbp(systolic blood pressure) ≥ 150 mmhg or \ 100 mmhg or \< 50 mmhg * history of drug abuse or positive urine drug screening results * women with pregnant, breast-feeding * caffeine \> 5 cups/day, alcohol \> 210 g/week, smoker \> 10 cigarettes /day or who are unable to stop caffeine intake, drinking alcohol and smoking until the last blood drawing for pk * subject who took ethical drug/herbal compound within 14 days, over-the-counter drug/vitamin supplements within 7 days and depot injection/implantation within 30 days prior to the first ip administration * subject who was enrolled in another clinical trial(including bioequivalence study) and administered drugs within 90 days prior to the first ip administration * subject with whole blood donation within 60 days or component blood donation within 30 days * not eligible to participate for the study at the discretion of investigator
characterization of bio-psychosocial pain profiles in the perioperative period

Conditions: Pain, Postoperative

Summary: this is a prospective descriptive correlational design looking to characterize postoperative pain variables across various procedures that historically have significant levels of persistent post-surgical pain

this is a two institution (naval medical center san diego and walter reed national military medical center) prospective descriptive correlational design looking to characterize postoperative pain variables across various procedures that historically have significant levels of persistent post-surgical pain. a total goal of 1500 subjects (750 subjects at walter reed national military medical center and 750 subjects at naval medical center san diego) will be queried regarding their postoperative pain experience following mastectomy, thoracic surgery, total knee arthroplasty, total hip arthroplasty, spinal fusion, and major abdominal surgery. descriptive multidimensional tools (the defense and veterans pain rating scale (dvprs) and the electronic pain assessment screening tool and outcomes registry (pastor) will be used preoperatively, as an inpatient, and up to 6 months postoperatively.

Eligibility criteria:
inclusion criteria: * be between the ages of 18 and 80 and having any of the following surgical procedures: mastectomy, thoracic surgery, total knee arthroplasty, total hip arthroplasty, spinal fusion, and major abdominal surgery. deers eligible exclusion criteria: * total hip/total knee arthroplasty revision younger than 18 years old refuse participation cannot understand english has cognitive deficiencies (subject unable to provide consent for the study, subject unable to complete initial post consent measures)
ixabepilone in treating patients with advanced urinary tract cancer

Conditions: Distal Urethral Cancer; Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter; Proximal Urethral Cancer; Recurrent Bladder Cancer; Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter; Recurrent Urethral Cancer; Regional Transitional Cell Cancer of the Renal Pelvis and Ureter; Stage III Bladder Cancer; Stage IV Bladder Cancer; Transitional Cell Carcinoma of the Bladder; Urethral Cancer Associated With Invasive Bladder Cancer

Summary: phase ii trial to study the effectiveness of ixabepilone in treating patients who have progressive or metastatic urinary tract cancer. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

objectives: i. determine the response rate of patients with advanced carcinoma of the urothelium treated with ixabepilone. ii. assess the toxicity of this drug in these patients. outline: patients are stratified according to prior treatment with taxanes (yes vs no). patients receive ixabepilone iv over 3 hours on day 1. treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Eligibility criteria:
inclusion criteria: * histologically confirmed transitional cell carcinoma (tcc) of the urothelium(renal pelvis, ureter, bladder, or urethra) * mixed histology carcinoma with a tcc component allowed * progressive regional disease * metastatic disease * failed 1 and only 1 prior systemic chemotherapy regimen containing cisplatin or carboplatin in the adjuvant, neoadjuvant, or metastatic setting * may have included taxane-based therapy * measurable disease outside prior irradiation field * previously resected and irradiated cns metastases with evidence of stable disease allowed * performance status - ecog 0-2 * granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * bilirubin no greater than 1.5 mg/dl * ast no greater than 2.5 times upper limit of normal * creatinine no greater than 1.5 mg/dl * no prior severe cardiovascular disease (american heart association class iii or iv heart disease) * no uncontrolled congestive heart failure * no ventricular dysrhythmia * no active unresolved infection requiring parenteral antibiotics within the past week * no other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or clinically unsuspected organ-confined prostate cancer treated with prior prostatectomy * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior systemic biologic response modifier therapy * see disease characteristics * at least 4 weeks since prior chemotherapy and recovered * see disease characteristics * at least 4 weeks since prior radiotherapy and recovered * no concurrent radiotherapy * see disease characteristics * at least 4 weeks since prior major surgery and recovered
the leaflex™ standalone study protocol

Conditions: Aortic Valve Stenosis

Summary: a prospective, multicenter, single-arm study aimed to assess safety and performance of the leaflex™ performer in the treatment of patients with symptomatic, severe aortic stenosis. subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure.


Eligibility criteria:
inclusion criteria: * patient with symptomatic, severe aortic stenosis who are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement. * patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent. exclusion criteria: * moderate or greater aortic regurgitation. * anatomic contraindications. * coronary, carotid, or vertebral artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease ≤ 1 month prior to index procedure. * aortic balloon valvuloplasty ≤ 3 months prior to index procedure. * stroke ≤ 12 months prior to index procedure. * history of a myocardial infarction ≤ 6 weeks prior to index procedure. * patients with clinically significant abnormality in cell blood count, history of bleeding diathesis or coagulopathy. * hemodynamic instability. * hypertrophic cardiomyopathy with obstruction. * left ventricle ejection fraction \<30%. * ongoing severe infection, including endocarditis, or sepsis. * life expectancy ≤ 12 months.
i-125 versus pd-103 for medium risk prostate cancer

Conditions: Prostate Cancer

Summary: hypothesis: the shorter half-life of pd-103 versus i-125, will increase the rate of tumor eradication. a total of 660 patients with ajc clinical stage t1c-t2a prostatic carcinoma (gleason grade 7 to 9 and/or psa 10-20 ng/ml) will be randomized to implantation with i-125 (144 gy) versus pd-103 (124 gy).

objective: the objective of this study is test the hypothesis that the shorter half-life of pd-103 versus i-125, will increase the rate of tumor eradication. research plan: a total of 660 patients with ajc clinical stage t1c-t2a prostatic carcinoma (gleason grade 7 to 9 and/or psa 10-20 ng/ml) will be randomized to implantation with i-125 (144 gy) versus pd-103 (124 gy). methodology: randomization will be accomplished by the method of random permuted blocks. cancer status will be monitored by yearly serial serum psa. treatment-related morbidity will be monitored by personal interview, using standard american urologic association and radiation therapy oncology group criteria at 1, 3, 6, 12 and 24 months. primary endpoint: time to treatment failure. patients with serum psa above 0.5 ng/ml two years or more after treatment will be considered to have residual or recurrent cancer and to have failed therapy.

Eligibility criteria:
inclusion criteria: * psa 4-10 ng/ml * gleason score 5 or 6

Keywords: radiation brachytherapy prostate cancer
rheumatic heart disease community streptococcal treatment program "reset"

Conditions: Rheumatic Heart Disease

Summary: the primary objective of this study is to determine the impact of a pragmatic rhd primary prevention program in uganda. the secondary objective are as follow: 1. to improve guideline-based care for sore throat through frontline healthcare provider education on clinical decision rules and guideline-based primary prevention. 2. to increase health seeking behavior for sore throat thorough a multifaceted community awareness campaign.

our intervention is designed as a service-oriented plan to be implemented through the primary healthcare structure and facilities of both the national health and private system. additional support will come from the education system, with participation from schools, teachers, patients, patient families, and the public. our intervention will focus on two of the more easily rectified impediments to primary prevention, namely (1) poor uptake of guideline-based treatments for group a streptococcal (gas) pharyngitis and (2) low levels of public awareness of the importance of sore throat care and treatment.

Eligibility criteria:
inclusion criteria: • has agreed to participate in the study via the study's informed consent/assent process. exclusion criteria: * known history of arf or rhd * any known co-morbid conditions (hiv, renal deficiencies, severe malnutrition, * among others) that have resulted in prescription of regular antibiotic prophylaxis * structural or functional cardiac defects, other than those consistent with rhd, that were known prior to or detected through echo screening (except patent foramen ovale, small atrial septal defect, small ventricular septal defect, small patent ductus arteriosus).
ischemic stroke and early vertical positioning (sevel)

Conditions: Early Mobilisation in Ischemic Stroke Patients

Summary: even if it is a daily questioning for the stroke physician, no concrete recommendation exists regarding the time-point of the mobilization of stroke patients. in this study, we will compare two mobilisation strategies: early versus delayed "verticalisation". 400 ischemic stroke patients will be included in this prospective randomized controlled trial, equally distributed in two groups. in the early mobilisation procedure the patient is allowed to go and sit outside of the bed the day after the stroke onset, whereas in the other arm, this procedure is delayed to the third day after stroke onset. the outcome in both groups will be assessed by the modified rankin scale at 3 months, which is commonly used in stroke study to investigate the functional outcome of the patients.


Eligibility criteria:
inclusion criteria: * age 18 years or older * persistent neurological impairment at the participated time, related to an ischemic stroke defined by a sudden neurological deficit. the neurological deficit must not accompany hemorrhage on cerebral tomodensitometry which occurs on the same day or the day previous to the participation * patient hospitalized in neurology department on the day of the participation * patient affiliated to the social security exclusion criteria: * malignant cerebral infarction, loss of consciousness, comatose with gcs under 13, cerebral herniation, life- threatening infarction. * minor neurological deficit defined by isolated facial palsy, dysarthria, hemianopia, sensitive impairment, or every clinical condition that let the physician thinks that the stay in the hospital would be less than 72 hours. * known intracranial stenosis above 50% linked to the current infarction * history of orthostatic neurological degradation * vomiting * deep venous thrombosis or suspicion of. * patients displaying a loss of autonomy with a rankin score \>3 previous to stroke onset. * patient's refusal * patient under legal protection

Keywords: cerebral infarction, mobilization, recovery
prevention of hepatitis b virus reinfection after liver transplantation with entecavir

Conditions: Liver Transplantation; Hepatitis B; Liver Disease

Summary: the purpose of this study is to determine whether hepatitis b immunoglobin can be discontinued early after hepatitis b virus (hbv) induced liver transplantation and be replaced by the nucleoside analogue entecavir to prevent hepatitis b reinfection.


Eligibility criteria:
inclusion criteria: * liver transplantation for hepatitis b induced endstage liver disease * absence of coinfection with hiv and hcv * female and male patients \>= 18 years of age exclusion criteria: * any evidence of other causes for endstage liver disease * patients that do not fulfill the criteria for liver transplantation

Keywords: hepatitis b liver transplantation shortterm hbig lamivudine resistance
remove lps registry

Conditions: Suspected or Diagnosed Endotoxemia Casued by Gram-negative Bacteria

Summary: this registry will collect and validate regulatory-grade real-world data (rwd) on the usage of the lps-adsorber and the outcomes from using the lps-adsorber in various patient populations (various sub-registries) that also have suspected endotoxemia. this data can be then used in real-world evidence (rwe) generation. it will also create reusable infrastructure to allow creation or affiliation with many additional rwd/rwe efforts both prospective and retrospective in nature.


Eligibility criteria:
inclusion criteria: * weight \> 30 kilos specific sub-registry criteria are possible. exclusion criteria: * none
kn026 combined with kn046 in subjects with her2 positive solid tumor

Conditions: HER2 Positive Solid Tumor

Summary: this is a phase ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of kn026 combined with kn046 in subjects with advanced her2 positive solid tumors.

the study is composed of 2 stages. stage 1 consists of dose escalation cohorts for determining the maximum tolerated dose (mtd) and recommended phase 2 dose (rp2d). part 2 consists of 4 tumor type expansion cohorts for expanding the information on clinical safety, clinical pharmacokinetics and antitumor activity in her2 positive patients.

Eligibility criteria:
inclusion criteria: * signed inform consent form (icf) * age ≥ 18 years and ≤ 75 years, male or female * histologically or cytologically documented advanced her2 positive solid tumor * received at least one prior standard therapy * at least one measurable lesion according to response evaluation criteria in solid tumors（recisit） v 1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate organ function * lvef≥ 50% (echo) * female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). contraception should be continued for a period of 24 weeks after dosing has been completed. * ability to comply with treatment, procedures and pharmacokinetics (pk) sample collection and the required study follow-up procedures exclusion criteria: * accepted any other anti-tumor drug therapies within 4 weeks before fist dose * accepted radiotherapy within 4 weeks before enrollment * an anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines * subjects are eligible with clinically controlled and stable neurologic function \>= 4 weeks, which is no evidence of cns disease progression; subjects with spinal cord compression and cancerous meningitis are not eligible * subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to \< 10 mg prednisone daily, inhaled steroids and topical use of steroids) * vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines) * pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study * severe chronic and active infection, need to system antibiosis/antiviral treatment * has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management * cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage

Keywords: kn026 kn046 her2 positive solid tumor